A Study of mRNA-1608, a Herpes Simplex Virus -2 (HSV-2) Therapeutic Candidate Vaccine, in Healthy Adults 18 to 55 Years of Age With Recurrent HSV-2 Genital Herpes

Genital Herpes Clinical Trial

Official title:

A Phase 1/2, Randomized, Observer-Blind, Controlled, Dose-Ranging Study of mRNA-1608, an HSV-2 Therapeutic Candidate Vaccine, in Healthy Adults 18 to 55 Years of Age With Recurrent HSV-2 Genital Herpes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06033261
• Other study ID #: mRNA-1608-P101
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: September 6, 2023
• Est. completion date: June 4, 2025

Study information

• Verified date: April 2024
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to generate safety and immunogenicity data and establish a proof-of-concept of clinical benefit of the mRNA-1608 vaccine candidate.

Description:

Participants with a history of recurrent genital herpes will be randomly assigned in a 1:1:1:1 ratio to receive mRNA-1608 at 1 of the 3 dose levels or control (BEXSERO) administered as 2 doses at 0 and 2 months (Day 1 and Day 57).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 365
• Est. completion date: June 4, 2025
• Est. primary completion date: June 4, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Participant has a diagnosis of genital HSV-2 infection for at least 1 year before the Screening Visit.

• Seropositive for HSV-2 as determined by Western Blot.

• Participant has a history of recurrent genital herpes defined as at least 3 and no more than 9 reported genital herpes recurrences in the 12 months preceding the Screening Visit, or if currently on suppressive therapy, prior to initiation of suppressive therapy.

• Willing to refrain from taking suppressive antiviral therapy from the Screening Visit until the end of the study.

• Willing to refrain from the use of episodic antiviral therapy during the three 28-day anogenital swabbing periods. Episodic therapy may be used outside the three 28-day swabbing periods.

• For female participants of childbearing potential: negative pregnancy test, adequate contraception, and not currently breastfeeding.

Exclusion Criteria:

• Prior immunization with a vaccine containing HSV antigens.

• History of any form of ocular HSV infection, HSV-related erythema multiforme, or HSV-related neurological complications.

• History of genital HSV-1 infection.

• History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) types 1 or 2 (HIV-1, HIV-2).

• Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA vaccine(s) or any components of the mRNA vaccines.

• Previously received BEXSERO or other vaccine to prevent serogroup B meningococcal disease (also known as meningitis B).

• History of allergic disease or reactions likely to be exacerbated by any component of BEXSERO vaccine.

• Has received or plans to receive any licensed or authorized vaccine, including COVID-19 vaccines, = 28 days prior to the first study injection (Day 1), or plans to receive a licensed or authorized vaccine within 28 days before or after study injection with the exception of licensed influenza vaccines, which may be received more than 14 days before or after any study injection.

Note: Other inclusion and exclusion criteria may apply.

Related Conditions & MeSH terms

• Genital Herpes
• Herpes Genitalis
• Herpes Simplex

Intervention

Biological:
• mRNA-1608
Sterile liquid for injection
• BEXSERO
A vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B.

Locations

Country	Name	City	State
United States	Velocity Clinical Research Cleveland	Beachwood	Ohio
United States	Cedars-Sinai Medical Center/Carbon Health	Beverly Hills	California
United States	Accel Clinical Sites Network - Cahaba Medical Care	Birmingham	Alabama
United States	Fenway Health	Boston	Massachusetts
United States	Velocity Clinical Research, Austin	Cedar Park	Texas
United States	Helios CR, Inc Fort Worth	Fort Worth	Texas
United States	Velocity Clinical Research	Grand Island	Nebraska
United States	DM Clinical Research	Houston	Texas
United States	Multi-Specialty Research Associates, Inc.	Lake City	Florida
United States	Johnson County Clin-Trials (JCCT)	Lenexa	Kansas
United States	Suncoast Research Associates, LLC	Miami	Florida
United States	Research Works	New Orleans	Louisiana
United States	Health Research of Hampton Roads	Newport News	Virginia
United States	Alliance for Multispecialty Research, LLC	Newton	Kansas
United States	Velocity Clinical Research	Norfolk	Nebraska
United States	M3 Wake Research, Inc.	Raleigh	North Carolina
United States	Rochester Clinical Research	Rochester	New York
United States	Sun Research Institute	San Antonio	Texas
United States	Acclaim Clinical Research	San Diego	California
United States	University of Washington Virology Research Clinic	Seattle	Washington
United States	DM Clinical Research	Southfield	Michigan
United States	DM Clinical Research	Tomball	Texas
United States	Noble Clinical Research	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)		Up to Day 64 (7 days after each injection)
Primary	Number of Participants with Unsolicited Adverse Events (AEs)		Up to Day 85 (28 days after each injection)
Primary	Number of Participants with Serious Adverse Events (SAEs)		Day 1 to Day 393 (end of study [EoS])
Primary	Number of Participants with Adverse Events of Special Interest (AESIs)		Day 1 to Day 393 (EoS)
Primary	Number of Participants with AEs Leading to Discontinuation From Study		Day 1 to Day 393 (EoS)
Primary	Number of Participants with Medically-Attended AEs (MAAEs)		Day 1 through 6 months after last study injection (Day 225)
Secondary	Number of Genital Herpes Recurrences, Counted Starting 14 Days After the Second Study Injection to 6 Months After Second Study Injection		Day 71 to Day 225
Secondary	Number of Genital Herpes Recurrences, Counted Starting 14 Days After the Second Study Injection to 12 Months After Second Study Injection		Day 71 to Day 393
Secondary	Change From Baseline (28 Days Prior to the First Study Injection) to 2 Months After the Second Study Injection in Genital Herpes Lesion Rate (Proportion of Days With Lesions Present)	To calculate the 'Change from Baseline', the herpes lesion rate during the timeframe of Day 85 to Day 113 will be compared against the herpes lesion rate during the timeframe of Day -27 to Day 1 (Baseline).	Baseline (Day -27 to Day 1), Day 85 to Day 113
Secondary	Change From Baseline (28 Days Prior to the First Study Injection) to 6 Months After the Second Study Injection in Genital Herpes Lesion Rate (Proportion of Days With Lesions Present)	To calculate the 'Change from Baseline', the herpes lesion rate during the timeframe of Day 197 to Day 225 will be compared against the herpes lesion rate during the timeframe of Day -27 to Day 1 (Baseline).	Baseline (Day -27 to Day 1), Day 197 to Day 225
Secondary	Change From Baseline (28 Days Prior to the First Study Injection) to 2 Months After the Second Study Injection in HSV-2 Genital Shedding Rate (Proportion of HSV-2 Deoxyribonucleic acid [DNA] Positive Anogenital Swabs)	To calculate the 'Change from Baseline', the HSV-2 genital shedding rate during the timeframe of Day 85 to Day 113 will be compared against the HSV-2 genital shedding rate during the timeframe of Day -27 to Day 1 (Baseline).	Baseline (Day -27 to Day 1), Day 85 to Day 113
Secondary	Change From Baseline (28 Days Prior to the First Study Injection) to 6 Months After the Second Study Injection in HSV-2 Genital Shedding Rate (Proportion of HSV-2 DNA Positive Anogenital Swabs)	To calculate the 'Change from Baseline', the HSV-2 genital shedding rate during the timeframe of Day 197 to Day 225 will be compared against the HSV-2 genital shedding rate during the timeframe of Day -27 to Day 1 (Baseline).	Baseline (Day -27 to Day 1), Day 197 to Day 225
Secondary	Geometric Mean Titer (GMT) of mRNA-1608 Antigen-Specific Binding Antibodies (bAbs) at 1 and 6 Months After the Second Study Injection		Days 85 and 225
Secondary	Geometric Mean Fold Rise (GMFR) of mRNA-1608 Antigen-Specific bAbs From Baseline to 1 and 6 Months After the Second Study Injection		Baseline (Day 1), Days 85 and 225
Secondary	Number of Participants With Vaccine Seroresponse	Seroresponse is defined by an increase in HSV-2 bAb levels at Day 85 and Day 225 =4-fold if baseline level is above the lower level of quantitation (LLOQ) or =4 × LLOQ if baseline bAb level is	Baseline (Day 1), Days 85 and 225